CSPT #4 EXAM 2025 QUESTIONS AND
ANSWERS
Respondents to the 2016 survey of sterile compounding practices identified several barriers to
compliance with USP Chapter 797 requirements. Which of the following is the most cited
barrier to comply with sterile compounding requirements? - ANS Financial and budget
restrictions.
The USP Chapter 797 and 800 stated that hazardous drugs should be stored in a negative-
pressure room with external ventilation and at least: - ANS 12 air changes per hour.
Which of the following is among the key elements of facility design in health care institutions
where hazardous drugs are prepared? - ANS A certified Class II biological safety cabinet in a
negative-pressure buffer room.
Section 503B of the Federal Food, Drug, and Cosmetic Act addresses which of the following? -
ANS Outsourcing Facilities.
Which of the following primary engineering controls are designed for compounding
nonhazardous sterile
preparations? - ANS Laminar air flow workbench and compounding aseptic isolator.
What is a media fill test intended to simulate? - ANS Ability to aseptically mix a compounded
sterile preparation
1Page
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, For those new to compounding, how many successful gloved fingertip tests must be done and
how many colony forming units (CFUs) are allowed? - ANS 3 sets of tests with no growth.
What are the two key components of viability monitoring? - ANS Electronic air sampling and
surface sampling
Which two solutions must be used at least daily to clean a primary engineering control used for
nonhazardous preparations? - ANS Germicidal detergent and sterile alcohol
Which of the following is TRUE when compounding in a compounding aseptic isolator or
compounding aseptic containment isolator? - ANS Sterile gloves are donned inside the
compounding isolator chamber, and placed over the gauntlet gloves
The Drug Quality and Security Act (DQSA) of 2013 Title 1 intent to: - ANS Distinguishes
regulation of traditional pharmacies and outsourcing facilities.
AND Provides more oversight of large-scale compounding facilities.
The DQSA addresses which of the following practices? - ANS The compounding of sterile
drugs for human use.
Outsourcing facilities, as defined under the section 503B of DQSA, must: - ANS I. comply with
CGMP requirements.
II. be inspected by FDA according to a risk-based schedule.
III. provide FDA with certain information about the products they compound.
Which of the following activities is considered "compounding" according to the Food and Drug
Administration's definition of "compounding"? - ANS A hospital creating a sterile admixture.
2
The PCAC has recommended that which of the following drugs be included on the "Do Not
Page
Compound" list? - ANS Rofecoxib
@COPYRIGHT FYNDLAY 2025/2026
ANSWERS
Respondents to the 2016 survey of sterile compounding practices identified several barriers to
compliance with USP Chapter 797 requirements. Which of the following is the most cited
barrier to comply with sterile compounding requirements? - ANS Financial and budget
restrictions.
The USP Chapter 797 and 800 stated that hazardous drugs should be stored in a negative-
pressure room with external ventilation and at least: - ANS 12 air changes per hour.
Which of the following is among the key elements of facility design in health care institutions
where hazardous drugs are prepared? - ANS A certified Class II biological safety cabinet in a
negative-pressure buffer room.
Section 503B of the Federal Food, Drug, and Cosmetic Act addresses which of the following? -
ANS Outsourcing Facilities.
Which of the following primary engineering controls are designed for compounding
nonhazardous sterile
preparations? - ANS Laminar air flow workbench and compounding aseptic isolator.
What is a media fill test intended to simulate? - ANS Ability to aseptically mix a compounded
sterile preparation
1Page
@COPYRIGHT FYNDLAY 2025/2026
, For those new to compounding, how many successful gloved fingertip tests must be done and
how many colony forming units (CFUs) are allowed? - ANS 3 sets of tests with no growth.
What are the two key components of viability monitoring? - ANS Electronic air sampling and
surface sampling
Which two solutions must be used at least daily to clean a primary engineering control used for
nonhazardous preparations? - ANS Germicidal detergent and sterile alcohol
Which of the following is TRUE when compounding in a compounding aseptic isolator or
compounding aseptic containment isolator? - ANS Sterile gloves are donned inside the
compounding isolator chamber, and placed over the gauntlet gloves
The Drug Quality and Security Act (DQSA) of 2013 Title 1 intent to: - ANS Distinguishes
regulation of traditional pharmacies and outsourcing facilities.
AND Provides more oversight of large-scale compounding facilities.
The DQSA addresses which of the following practices? - ANS The compounding of sterile
drugs for human use.
Outsourcing facilities, as defined under the section 503B of DQSA, must: - ANS I. comply with
CGMP requirements.
II. be inspected by FDA according to a risk-based schedule.
III. provide FDA with certain information about the products they compound.
Which of the following activities is considered "compounding" according to the Food and Drug
Administration's definition of "compounding"? - ANS A hospital creating a sterile admixture.
2
The PCAC has recommended that which of the following drugs be included on the "Do Not
Page
Compound" list? - ANS Rofecoxib
@COPYRIGHT FYNDLAY 2025/2026
